Sotalol 80 mg Tablets — Generic For Betapace — Apotex

Medication Summary

Medication Summary: This section summarizes DailyMed drug label information to make the label easier to understand. It is not a substitute for the official label, pharmacist counseling, prescriber instructions, or medical advice.

Overview

Sotalol hydrochloride tablets are an antiarrhythmic medicine used for documented, life-threatening ventricular arrhythmias and for helping maintain normal sinus rhythm in patients with atrial fibrillation or atrial flutter who are highly symptomatic and currently in sinus rhythm.

The label warns that this medicine can cause life-threatening ventricular arrhythmias linked to QT interval prolongation. Because of this risk, oral sotalol should be started or restarted in a facility that can provide cardiac resuscitation and continuous ECG monitoring.

Dosing is based on the condition being treated and may need adjustment for kidney function. The label also says to avoid certain drug combinations and to monitor for effects such as slow heart rate, low blood pressure, worsening heart failure, and changes in blood sugar.

The tablets are available in multiple strengths and are white to off-white, capsule-shaped, scored tablets with identifying imprints that differ by strength and formulation.

Storage Information

stored at 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] and ambient humidity. STORAGE AND HANDLING Sotalol hydrochloride tablets, USP are available as follows: 80 mg tablets: White to off-white capsule shaped, scored tablets, imprinted “APO” on one side and “SO” bisect “80” on the other side. Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container [see USP].

Key Counseling Points

• Take sotalol exactly as prescribed and do not change the dose or dosing interval on your own.
• The first dose or a restart may need to happen in a monitored facility because of the risk of serious heart rhythm problems.
• Keep scheduled ECG and lab monitoring appointments, including kidney function and electrolyte checks if ordered.
• Tell your prescriber about all medicines you take, especially other antiarrhythmics, QT-prolonging drugs, digoxin, diltiazem, verapamil, insulin, or diabetes medicines.
• Do not take oral sotalol within 2 hours of antacids containing aluminum oxide and magnesium hydroxide.
• If you miss a dose, take the next dose at the usual time; do not double the dose or shorten the dosing interval.
• Do not stop sotalol suddenly unless instructed, because abrupt stopping can worsen heart problems.
• Report symptoms such as very slow heart rate, dizziness, shortness of breath, fainting, swelling, or worsening heart failure.
• Tell your healthcare provider if you have diabetes, because beta-blockers may mask low blood sugar warning signs and affect glucose control.
• If you are pregnant or breastfeeding, the label advises special caution and says not to breastfeed while taking sotalol.

Helpful Patient Education

Sotalol hydrochloride tablets are prescription antiarrhythmic medicines used to treat certain serious heart rhythm disorders, including documented life-threatening ventricular arrhythmias and to help delay recurrence of atrial fibrillation or atrial flutter in selected patients. The label emphasizes careful initiation, ECG monitoring, and dose adjustment based on kidney function because of the risk of QT prolongation and life-threatening arrhythmias.

This product is supplied as white to off-white, capsule-shaped, scored tablets with strength-specific imprinting. Patients should follow the prescribing information closely, including guidance on missed doses, drug interactions, and monitoring for side effects such as bradycardia, hypotension, and worsening heart failure.

Medication Summary last generated: 2026-06-19 05:57:17